Discussion |
PRINCIPLE FINDINGS
The results of this retrospective, uncontrolled observational study demonstrate that Hackett-Hemwall dextrose Prolotherapy helps decrease pain and improve the quality of life of patients with unresolved foot and toe pain. This treatment gave 63% of patients greater than 75% pain relief, and 84% of patients achieved 50% or more pain relief. One-hundred percent of patients stated their pain and their life in general was better after receiving Prolotherapy. Notable improvements in other quality of life issues included depression, anxiety, sleep, walking ability, exercise ability and medication usage.
For the 42% (8) of patients who stated their doctors said no other treatment options were available for their pain, the results were very similar. Clinically relevant decreases in pain and stiffness were also seen in this subgroup.
STRENGTHS AND WEAKNESSES
Our study cannot be compared to a clinical trial in which an intervention is investigated under controlled conditions. Instead, it is aimed to document the response of patients with unresolved foot and toe pain to the Hackett-Hemwall technique of dextrose Prolotherapy at a charity medical clinic. Clear strengths of the study are the numerous quality of life parameters that were examined. Such quality of life issues as walking ability, stiffness, athletic (exercise) ability, sleep, anxiety and depression, in addition to pain level, are important factors affecting the person with unresolved foot/toe pain. Decreases in medication usage were also documented. The improvement in such a large number of variables treated solely by Prolotherapy is likely to have resulted from Prolotherapy. So while there is no medical test to document pain improvement or the progress with Prolotherapy, an increased ability to walk, exercise, work and use less medications are objective changes.
The quality of the cases treated in this study is also a strength. The average person in this study had unresolved foot or toe pain for four years six months, and eight (42%) of the patients were either told by their MD(s) that there was no other treatment option for their pain. So clearly this patient population represented chronic unresponsive foot and toe pain. A follow-up since their last treatment of an average of eighteen months since their last Prolotherapy session was also a strength.
Because this was a charity medical clinic with limited resources and personnel, the only therapy that was used was Prolotherapy. The Prolotherapy treatments could only be given every three months. In private practice, the Hackett-Hemwall technique of dextrose Prolotherapy is typically given every four to six weeks. If a patient is not improving or has poor healing ability, the Prolotherapy solutions may be changed and/or strengthened or the patient is advised on additional measures to improve their overall health. This can include advice on diet, supplements, exercise, weight loss, changes in medications, additional blood tests, and/or other medical care. Often patients are weaned immediately off of anti-inflammatory and narcotic medications that inhibit the inflammatory response that is needed to produce a healing effect from Prolotherapy. Since this was not done in this study, the results at this charity clinic are an indication of the lowest level of success with Hackett-Hemwall dextrose Prolotherapy. This makes the results even that much more impressive.
A shortcoming of our study is the subjective nature of some of the evaluated parameters. Subjective parameters of this sort included pain, stiffness, anxiety, and depression levels. The results relied on the answers to questions by the patients. Changes in these parameters that occurred with Prolotherapy were analyzed by an independent data analyst. No X-ray and MRI correlation for diagnosis and response to treatment was observed. Lack of documentation in the patients’ charts of physical examinations made categorization of the patients into various diagnoses categories impossible.
INTERPRETATION OF FINDINGS
Hackett-Hemwall dextrose Prolotherapy was shown to be very effective in eliminating pain and improving the quality of life in this group of patients with unresolved foot and toe pain. This included the subgroup of patients who were told by their MD(s) that no other treatment options were available for their pain. Current conventional therapies for unresolved foot pain include medical treatment with analgesics, non-steroidal anti-inflammatory drugs, anti-depressant medications, steroid shots, trigger point injections, muscle strengthening exercises, physiotherapy, weight loss, rest, massage therapy, manipulation, orthotics, surgical treatments including fusions, multidisciplinary group rehabilitation, education and counseling. The results of such therapies often leave the patients with residual pain.30-32 Because of this, many patients with chronic foot pain are searching for alternative treatments for their pain. Searching for alternatives, simply put, are patients who either cannot find relief with traditional therapies or do not like the options, especially if surgery is recommended. One of the treatments that chronic foot/toe pain patients are trying instead of surgery is Prolotherapy.33
Prolotherapy is the injection of a solution for the purpose of tightening and strengthening weak tendons, ligaments or joint capsules. Damage to connective tissues such as these can cause misalignment of the joint surfaces. Metatarsophalangeal (forefoot/toe) pain most commonly results from misalignment of the joint surfaces with altered foot biomechanics, causing joint subluxations, capsular impingement and joint cartilage destruction (osteoarthrosis).34 Many forefoot deformities such as hallux rigidus (bunion) result from the failure of deep transverse ligaments in the sole of the foot, allowing for an abnormal “splay” of the forefoot which progressively worsens, causing the big toe (hallux) to drift and become deformed.35 Prolotherapy works by stimulating the body to repair these soft tissue structures. It starts and accelerates the inflammatory healing cascade by which fibroblasts proliferate. Fibroblasts are the cells through which collagen is made and by which ligaments and tendons repair. Prolotherapy has been shown in one double-blinded animal study in a six-week period to increase ligament mass by 44%, ligament thickness by 27% and the ligament-bone junction strength by 28%.36 In human studies on Prolotherapy, biopsies performed after the completion of Prolotherapy showed statistically significant increases in collagen fiber and ligament diameter of 60%.37, 38 Ligament injury has been implicated as the cause of degenerative osteoarthritis in joints.39 This is significant since a potential cause of unresolved foot pain is ligament weakness, such as in the calcaneonavicular (spring) ligament, which can lead to flattening of the arch and degenerative osteoarthritis. Ligament injury is also a potential cause of metatarsalgia.40 Thus, Prolotherapy has the potential to stop the degenerative joint disease process and some preliminary and anecdotal evidence shows that in some cases it can reverse it.41
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